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LENENG TRADE LTD

⚠️ Moderate Risk

FEI: 3016740533 • North Point, Hong Kong Island • HONG KONG

FEI

FEI Number

3016740533

📍

Location

North Point, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

Flat 1802b, Fortress Tower; 250 King'S Road, North Point, Hong Kong Island, Hong Kong

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
2/1/2021
Latest Refusal
2/1/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

821×

RX LEGEND

The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).

Refusal History

DateProductViolationsDivision
2/1/2021
86LPLLENSES, SOFT CONTACT, DAILY WEAR
16DIRECTIONS
82RX LEGEND
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LENENG TRADE LTD's FDA import refusal history?

LENENG TRADE LTD (FEI: 3016740533) has 1 FDA import refusal record(s) in our database, spanning from 2/1/2021 to 2/1/2021.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. LENENG TRADE LTD's FEI number is 3016740533.

What types of violations has LENENG TRADE LTD received?

LENENG TRADE LTD has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about LENENG TRADE LTD come from?

All FDA import refusal data for LENENG TRADE LTD is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.